FDA Medical Device Recalls (openFDA)
Janus Trade Group: B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
- Recall number
- Z-0509-2021
- Recalling firm
- Janus Trade Group
- Product
- B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
- Status
- Terminated
- Initiated
- 2020-03-23
- Posted
- 2020-11-30
- Terminated
- 2021-05-20
- Reason
- Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.
- Root cause
- No Marketing Application
- Action
- Between March 13-25, 2020, Janus Trade Group made phone contact with customers requesting to check if customers had product on hand. If customers had product on hand, they were asked to send it back to JTG for a full refund.
- Quantity
- 1365 cases (200 units/case)
- Distribution
- US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.
- Lot, serial or model codes
- Lots 18L23G8271 17A20G8273 18M02G8315 16H16G8261 18K18G8244 17D08G8241 16H16G8261 15H25G8315 18G15A272 18G31G8316 18G31G8392 17H20G8391 18M02G8315 18M02G8315 18F29G8362 18D01G8273 17K08G8272 17K08G8273 17G10G8261 19A12G8272 19A12G8272 18H17G8272 18H17G8272 18F26G8303 18H04G8261 15F25G8395 17K27G8304 17C16G8304 17H02G8392 17F15G8302 17M10G8271 17M10G8273 17M15G8261 17C17G8302 17C18G8305 18M20G8271 18L29G8271 18K08G8263 18HI8G8243 18F25G8272 18F25G8272 17M11G8273 17H23G8272 17H23G8271 17H23G8271 18L23G8271 18L23G8271 17A20G8273 17A20G873 17A20G8273 17D08G8241 17D08G8241 17D08G8241 16N24G8303 16H30G8303 16H30G8304 16L0G8275 14N10G8274 16H16G8261
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3016611533
- Firm city
- Eatontown
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28